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Sep 30, 2019

 
NMPA officially joins Medical Device Regulators Forum (IMDRF) National Competent Authorities Report (NCAR) Exchange Program
On September 19, 2019 the IMDRF approved the Chinese National Medical Products Administration (NMPA) to join the IMDRF National Competent Authorities Report (NCAR) Exchange Program.

The IMDRF NCAR Exchange Program was established to set up channels for sharing information on medical device safety among drug regulatory agencies of different countries, enabling member countries to exchange information in a timely manner on medical device adverse events that could trigger serious public health issues or indicate potential risk trends.

NMPA participation in the mechanism provides China with access to safety information on international medical device adverse events and facilitates evaluation and control of the risks associated with imported products, so that NMPA is better positioned to protect and promote public health.

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Safer Technologies Program for Medical Devices
FDA issued a draft document of Safer Technologies Program for Medical Devices on September 19, 2019 and opened for public comment until November 18, 2019.

The FDA is introducing a new, voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program; for example, this may include devices treating or diagnosing non-life-threatening or reasonably reversible conditions. Devices and device-led combination products are eligible for this program if they are subject to review under a premarket approval application (PMA), De Novo classification request (“De Novo request”), or premarket notification (510(k)). Consistent with the Agency’s statutory mission to protect and promote public health, FDA believes that this “Safer Technologies Program” or “STeP” will help patients have more timely access to these medical devices and device-led combination products by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, De Novo marketing authorization, and 510(k) clearance. FDA has modeled STeP on the principles and features of FDA’s Breakthrough Devices Program as mandated in section 515B of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 360e-3) and further described in the FDA “Breakthrough Devices Program” guidance document. As resources permit, FDA intends for STeP to incorporate similar features offered under the Breakthrough Devices Program, such as interactive and timely communications, early engagement on Data Development Plans (DDP), prioritized review, and senior management engagement.

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EMA EudraVigilance Registration Manual
On September 25, 2019 EMA issued EMA EurdaVigilance Registration Manual.

To set-up a new organization in EudraVigilance, a series of steps need to be followed: 1) A person within the organization needs to be chosen as being responsible for managing the organization and its users in the EudraVigilance system. If the organization is a marketing authorization holder the primary responsible person will be a Qualified Person for Pharmacovigilance (QPPV); 2) Register for an EMA user account in the EMA Account Management portal if you do not already have one; 3) Check Organization Management System (OMS): if your organization is not present in OMS it will need to be registered; 4) Submit request to be registered as the responsible person for the organization; 5) Complete organization registration details in the EudraVigilance restricted area; 6) Set up the transmission mode; 7) Raise Service desk ticket to set up gateway connection or a webtrader connection

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New Organization First User QPPV/RP or Change of EU QPPV/RP
On September 25, 2019 EMA informed that sponsors need to notify EMA in case of new organization first user QPPV/RP or change of EU QPPV/RP.

If a change of qualified person for pharmacovigilance/responsible person for EudraVigilance (QPPV/RP), named person or legal representative within the organization occurs, sponsors need to notify EMA.

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Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorization holders (MAHs)
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP) in a no-deal Brexit.

As part of their ongoing Brexit advice, the UK Medicines & Healthcare products Regulatory Agency (MHRA) released a guidance note entitled "Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorization holders" on the 26th September 2019. This guidance describes the aspects of the EU guidance on GVP that will no longer apply to the MHRA and UK MAHs or are to be read subject to modification in a no-deal Brexit.

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Policy for Device Software Functions and Mobile Medical Applications
On September 27, 2019 the FDA issued this guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile or on other general-purpose computing platforms.

The FDA recognizes the extensive variety of actual and potential functions of software applications (apps) and mobile apps, the rapid pace of innovation, and their potential benefits and risks to public health. The FDA is issuing this guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”) or on general-purpose computing platforms. Given the rapid expansion and broad applicability of software functions deployed on mobile or other general-purpose computing platforms, the FDA is issuing this guidance document to clarify the subset of software functions to which the FDA intends to apply its authority.

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Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
FDA issued a final guidance on Medical Device Data Systems for industry and FDA staff on September 27, 2019. The policy described in this guidance document is also consistent with the Agency’s updated guidance entitled “Policy for Device Software Functions and Mobile Medical Applications,” originally issued on February 9, 2015, with the title “Mobile Medical Applications.”

The FDA recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology. The foundation for such inter-communication is hardware and software, typically referred to as medical device data systems (MDDS) that transfer, store, convert formats, and display medical device data or medical imaging data.

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Clinical Decision Support Software
FDA issued a draft guidance document on Clinical Decision Support Software on September 27, 2019 and opened for public comment until December 26, 2019.

The FDA has long regulated software that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including software that is intended to provide decision support for the diagnosis, treatment, prevention, cure, or mitigation of diseases or other conditions (often referred to as clinical decision support software). This guidance provides clarity on the scope of FDA’s oversight of clinical decision support software intended for health care professionals, patients, or caregivers.

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